Schering's Integrilin; Merck's Potential Wafarin Successor: Each to Face New Pressures. . . .

Integrilin (made by Schering-Plough) is only about a $300 million per year in sales revenue drug -- but it faces the increasingly-likely prospect of drastic market share loss when the next generation of clot-reduction drugs, primarily the Sanofi-Aventis candidate otamixaban is cleared for sale. Sanofi's candidate greatly outperformed in a recent Phase II clinical trial, per The Wall Street Journal, this morning:

. . . .Sanofi said patients treated with otamixaban in a phase two trial had a lower rate of deaths, second heart attacks or other complications compared to those receiving standard treatment with heparin and Integrilin, a drug marketed by Schering-Plough. . . .

Separately, Bristol-Myers-Squibb's now 50 year old wafarin-franchise has been under siege for years (generics long-available), but it suddenly faces a potential category killer -- a new drug, Pradaxa, from Boehringer Ingelheim, per Reuters' Matthew Goldstein:

. . . .Patients at risk of stroke due to an irregular heartbeat should soon have a viable alternative to 50-year-old warfarin, after a new pill from Boehringer Ingelheim beat expectations in a major clinical study. . . .

Other oral anticoagulants in development include Pfizer and Bristol's apixaban and Merck's betrixaban, both of which are further behind Pradaxa and Xarelto in testing. . . .

A pivotal trial involving more than 18,000 patients found a 150 milligram dose of Pradaxa, or dabigatran, given twice daily reduced the risk of stroke and systemic embolism by 34 percent compared to warfarin. . . .

Both studies were announced at the European Society of Cardiology meetings in Barcelona, yesterday. We'll keep an eye on these, as they progress.